ORION News

MHRA AUDIT - MARCH 2004

ORION Clinical Services Ltd. has recently been a hive of activity as all employees prepared for the long awaited MHRA inspection.

ORION was one of the final companies to participate in the MHRA Voluntary Inspection programme in March 2004. From May 2004, all such MHRA inspections will be mandatory under the European Clinical Trials Directive.

ORION’s inspection occurred in two parts. The first part took place at ORION’s global headquarters in Greater London on 22nd to 25th March 2004, whilst the second part of the inspection took place at an Investigator site on 21st July 2004.

One of the most important aspects of the Inspection was the preparation, and to ensure 'complete readiness' a working party was initiated with representatives from each department.

Prior to the Inspection, the MHRA inspectors had requested our SOPs and a comprehensive list of the clinical trials being conducted by ORION, including the number of countries participating, number of sites and number of patients required per trial. The list also documented ORION’s contractual responsibilities, including the names of the CRAs and Project Managers responsible for the trials.

From this list, two trials were identified by the Inspectors to be reviewed. Written permission was obtained from the sponsors.

During the inspection, staff were interviewed from all disciplines and levels, to ensure that we all had a clear understanding of our roles in relation to our CV’s, Job Descriptions and Training Records, and not forgetting our SOPs !!

The references used by the Inspectors to establish compliance were: